05/09/2006

Reviewing of Orphan Medicines regulation

Five years after EU regulation on orphan medicinal products, a study has demonstrated that incentives from the EU and Member States to research, produce and market orphan medicinal products, have resulted in the market authorisation of 22 new drugs in the fields of cancer, metabolic disorders, immunology, and cardiovascular and respiratory disorders. More than 450 applications for orphan disease medicines have been submitted.

“Already, more than 1 million patients suffering from orphan diseases in the Community may potentially benefit from these new 22 orphan medicines authorised during the first five years of application of Regulation (EC) No 141/2000. In addition, there are good grounds for assuming that the legislation has stimulated industrial activity leading to company creation with promising high-tech potential” the Commission says.

Link Commission: ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/orphan_en_06-2006.pdf
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